Registered outcomes13

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 13 of 13

List	Outcome	Time frame	Description
Primary	Stage 1: Successful Cannulation Sessions	Up to 24 weeks	Number of dialysis sessions with successfully cannulated for dialysis treatment of the fistula
Primary	Stage 1: Number of Sticks	Up to 24 weeks	The number of times a needle penetrated the skin during a cannulation attempt
Primary	Stage 1: Number of Needle Advancements	Up to 24 weeks	How many times a needle was advanced, regardless of how many needles were used
Primary	Stage 1: Number of Cannulation Related Infiltrations	Up to 24 weeks	Perforation of the side or deep wall of the fistula resulting in pain, swelling, hematoma formation, or temporary or permanent loss of blood flow through the needle.
Primary	Stage 1: Presence and Severity of Infiltration Related Hematoma	Up to 24 weeks	Grade 1 - Stable hematoma and patient is able to initiate hemodialysis via the fistula as intended. Grade 2 - Stable hematoma, but patient is unable to initiate dialysis via the fistula as intended, or requires the use of a catheter or an intervention to use the fistula for hemodialysis, for one or more dialysis treatments. Grade 3 - Major complication where the vessel has ruptured. Hematoma is unstable and requires treatment to save fistula or fistula is lost.
Primary	Stage 1: Missed Dialysis Session	Up to 24 weeks	Number of missed dialysis due to a cannulation failure or injury
Primary	Stage 1: CVC Used	Up to 24 weeks	Whether a catheter was used for one or two needles due to an inability to cannulate or cannulation failure
Primary	Stage 1: CVC Placement	Up to 24 weeks	Whether a catheter was placed for dialysis due to cannulation failure or injury
Primary	Stage 1: Blood Stream Infections	Up to 24 weeks	Number of bloodstream infections
Primary	Stage 1: Freedom from device related adverse events	Up to 24 weeks	Number of device related adverse events
Primary	Stage 1: Cannulator Experience	Up to 24 weeks	Cannulator experience questionnaire to be completed before the first subject is treated and after the last subject has finished Stage 1. Answer can range from Strongly Disagree (1) to Strongly Agree (7)
Primary	Stage 2: Patient Experience	Up to 24 weeks	Patient experience questionnaire to be completed before the end of Stage 2. Using AF-VAQ, Answer can range from Strongly Disagree (1) to Strongly Agree (7)
Primary	Stage 2: Freedom from device related adverse events	Up to 24 weeks	Number of device related adverse events

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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GET https://conductscience.org/api/trials/v1/NCT07891741/registered

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